WHO疫苗预认证及我国疫苗预认证的相关考虑

Introduction of WHO's Vaccine Prequalification Programme and Discussion on the Scientific Review Issues Identified During Vaccines Assessment by WHO

随着我国药品监管当局通过世界卫生组织(WHO)的疫苗监管体系评估以及国内首个乙脑疫苗通过了WHO的疫苗预认证。越来越多的中国疫苗企业向WHO提出了疫苗的预认证申请。生产国监管当局在WHO疫苗预认证过程中发挥了重要作用。文章拟通过WHO疫苗预认证程序简介、WHO在疫苗预认证过程中与疫苗科学审评相关的一些集中问题的反馈和探讨,为今后的中国疫苗企业通过WHO疫苗预认证提供一些启示。

With the acknowlegement of the national regulatory authority assessment（ NRA） by WHO and the successful registration of the JE vaccine as the first WHO prequalification case in China,more and more Chinese manufacturers have made the WHO prequalification applications. NRA plays an improtant role in the procedure of Prequalification（ PQ）. Though the introduction of procedure of WHO prequalification of vaccines and the discussion on the scientific review issues identified during vaccines assessment by WHO,this paper is drafted to hint the thinking points of WHO which may be benefitial for the following PQ application of the Chinese manufacturers.